Events

Recall of Single Use Instruments including Scissors, forceps, and suckers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00153-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00153-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Thermo fisher scientific received a labelling concern that a sterile instrument used during surgical procedures was not labelled as a single use instrument and that there could be the possibility of reuse.The devices affected are manufactured as single use instruments, and are safe for use as single use instruments. when used as single use instruments the devices do not pose a risk to human health and are safe to use within the scope of their artg inclusion.
  • Action
    Thermo Fisher Scientific is advising users to keep the notification in a prominent position. The manufacturer is currently working with their notified body on a scope extension but due to the time required to complete this, a resolution may not be achieved for 6 to 12 months.

Device

Single Use Instruments including Scissors, forceps, and suckers
  • Model / Serial
    Single Use Instruments including Scissors, forceps, and suckersMultiple products affectedAll lots affected ARTG Numbers: 296281, 296277, 296279, 296278, 296276, 296280, 296240, 296260, 296315
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd